Multi-Analyte In-line Sensor for Biomanufacturing Applications Based on Analyte-Responsive Smart Hydrogels.

Applied Biosensors LLC in collaboration with Merck & Co., Inc. and MilliporeSigma, is developing InSens4™, an in-line multi-analyte sensor that can simultaneously monitor Glucose, Lactate, Osmolality, and pH values during bioproduction.
Categories
Process control
Project status
100% Completed

Industry Need

Current process analytical techniques (PAT) in biomanufacturing are generally cost-prohibitive, ineffective, skill-intensive, and fail to support the growing demand for continuous manufacturing.

Solution

The team will address the current PAT by developing InSens4™ The team will address the current PAT by developing InSens4™, an in-line multi-analyte sensor that can simultaneous monitor Glucose, Lactate, osmolality, and pH values during bioproduction., an in-line multi-analyte sensor that can simultaneous monitor Glucose, Lactate, osmolality, and pH values during bioproduction.

Outputs/Deliverables

  • Demonstrated the responsiveness and integrity of the system (hydrogels, sensor housing, and reader electronics) through data and results from multiple CHO cell-culture runs (perfusion and fedbatch). Data predictions show an accuracy of ±5% accuracy compared to off-line measurements.
  • Developed scalable, reliable, and consistent manufacturing processes manufacturer single-use probe and reader. This involves standard operating procedures, process protocols, inspection, and shipping criteria.
  • Investigated InSens4™ stability under standard gamma and autoclave sterilization conditions.

Impacts

Publications

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Project Lead

Applied Biosensors

Applied Biosensors

Participating Organizations

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono